BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 23MM

    MDR report key: 3980741 · Received August 5, 2014

    Report

    Report Number
    2015691-2014-01786
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 10, 2014
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P130009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE, DEVICE MALPOSITION REQUIRING INTERVENTION IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE MULTIPLE PATIENT AND PROCEDURAL FACTORS THAT ALONE OR IN COMBINATION CAN CAUSE OR CONTRIBUTE TO AORTIC MALPOSITION, INCLUDING IMPROPER POSITIONING PRIOR TO DEPLOYMENT, POOR IMAGE INTENSIFIER ANGLE, POOR COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, SEVERE SEPTAL HYPERTROPHY, MINIMALLY OR SEVERELY CALCIFIED AORTIC LEAFLETS, PRESERVED EJECTION FRACTION, SIGNIFICANT MITRAL ANNULAR CALCIFICATION (MAC), LOSS OF PACING CAPTURE, AND MOVEMENT OF THE DELIVERY SYSTEM BY THE OPERATOR. THE THV TRAINING MANUALS INSTRUCT THE OPERATOR ON PROPER POSITIONING AND DEPLOYMENT OF THE VALVE, INCLUDING ALL PROCEDURAL AND ANATOMICAL CONSIDERATIONS. PHYSICIANS ARE EXTENSIVELY TRAINED BY EDWARDS BEFORE THEY ARE QUALIFIED TO USE THE SAPIEN THV. TRAINING INCLUDES PATIENT SCREENING, DEVICE PREPARATION, APPROACH, DEPLOYMENT, IMAGING, PROCEDURE-SPECIFIC TRAINING MANUALS AND PROCTORED PROCEDURES. THE CORRECT ALIGNMENT AND POSITIONING OF THE DEVICE AT THE POINT OF DEPLOYMENT IS EMPHASIZED AS A KEY FACTOR TO THE PLACEMENT AND FIXATION OF THE DEVICE. OPERATORS ARE ALSO INSTRUCTED TO USE FLUOROSCOPY AS THE PRIMARY METHOD OF VISUALIZATION FOR POSITIONING AND DEPLOYMENT. IN PATIENTS WITH HIGH-RISK ANATOMICAL FEATURES FOR AORTIC MALPOSITION (I.E. MINIMAL LEAFLET CALCIFICATION, SEVERE SEPTAL HYPERTROPHY), (B)(6) MAY PROVIDE INDICATION OF POTENTIAL BALLOON MOVEMENT DURING VALVE DEPLOYMENT. IN THIS CASE, IT WAS REPORTED THAT THE CAUSE FOR THE AORTIC MALPOSITION WAS THE EXCEEDING SMALL VENTRICULAR CAVITY AND THE RELATIVE HEALTH OF THE LEFT VENTRICLE (LV) THAT MADE POSITIONING VERY DIFFICULT. THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    DURING TRANSFEMORAL IMPLANTATION OF A 23MM SAPIEN XT VALVE, THE VALVE WAS PLACED TOO HIGH RESULTING IN MODERATE PARAVALVULAR LEAK (PVL) VIA TEE. THE VALVE WAS POSITIONED APPROXIMATELY 50:50 BUT LANDED 90:10 AORTIC/VENTRICULAR. AN ADDITIONAL 1CC WAS ADDED TO THE SYSTEM AND POST DILATATION WAS PERFORMED WITH NO IMPROVEMENT. HEMODYNAMICALLY THE PATIENT REMAINED STABLE ALTHOUGH DIASTOLIC PRESSURE WAS IN THE MID TO HIGH 30'S. THE SECOND VALVE WAS DEPLOYED WITH A RAPID PACING RATE OF 180 BPM WITH THE INTENT OF MINIMIZING ANY EJECTION OR MOVEMENT OF THE HEART. DURING DEPLOYMENT, THE VALVE AGAIN TRAVELED AORTIC AND DESPITE EFFORTS TO ADVANCE DURING DEPLOYMENT, THE SECOND VALVE WOUND UP IN THE SAME SPOT AS THE FIRST (90:10 A/V). THE PVL AND PRESSURE REMAINED UNCHANGED. POST DILATATION WAS PERFORMED AGAIN WITH NO IMPROVEMENT. A THIRD VALVE WAS THEN PREPPED AND ULTIMATELY DEPLOYED IN A 60:40 AORTIC POSITION. AGGRESSIVE POST-DILATION WAS ATTEMPTED TO FLARE THE BOTTOM OF THE FRAME IN THE LVOT. THIS DID DECREASE THE AMOUNT OF PVL MARGINALLY BUT PATIENT WAS LEFT WITH MODERATE PVL. THE PROCEDURE WAS STOPPED AT THIS POINT AND PATIENT WAS EXTUBATED IN THE ROOM AND TRANSFERRED TO ICU IN STABLE CONDITION. THE COAXIAL ALIGNMENT OF THE VALVE AND DELIVERY SYSTEM, AND THE IMAGE INTENSIFIER ANGLE, WAS GOOD. PER REPORT, THE EXCEEDINGLY SMALL VENTRICULAR CAVITY AND THE RELATIVE HEALTH OF THE LV CONTRIBUTED TO THE EVENT. THE NOSECONE WAS ESSENTIALLY AT THE APEX OF THE VENTRICLE, IT WAS NOT MOVING FREELY ON THE WIRE AND ANY FORWARD MOVEMENT ATTEMPTED BY THE OPERATOR RESULTED IN DELIVERY SYSTEM "BACKING OUT". THE LVEF WAS NORMAL (60%) AND THEREFORE EVEN RAPID PACING AT HIGH RATES DID NOT ELIMINATE THE VENTRICULAR FIBRILLATION AND THAT "MOVEMENT OR VIBRATION" IN THE LVOT MAY HAVE RESULTED IN AORTIC MOVEMENT WHEN BALLOON/DELIVERY SYSTEM MADE CONTACT WITH LVOT AS INFLATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457954 EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE, 23MM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9300TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention